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Reporte zur Charge UJ679AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2 MO 1 TX 1 AZ 1 LA 1

VAERS 2618040

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
MO
Alter
0,5
Geschlecht
F
Eingang
20.04.2023
Impfdatum
09.12.2022
Beginn
12.04.2023
Tage bis Beginn
124,0
Dosis
3
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

administered the products ACTHIB but the diluent was expired with no reported adverse event; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional. This case involves 6 months old female patient who experienced administered the products acthib but the diluent was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; POLIO VACCINE INACT (ipv) for Immunisation; and ROTAVIRUS VACCINE for Immunisation. On 09-Dec-2022, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection dose 1 of 0.5ml lot number 28-MAY-2023, 28-Mar-2023 via intramuscular route in right thigh. On 09-Feb-2023 she also received a dose of the same vaccine with dose 2 of 0.5ml lot number 28-MAY-2023, via intramuscular route in right thigh. On 12-Apr-2023 she also received a dose 3 of the same vaccine with an dose 3 of 0.5ml lot number 28-MAY-2023, 28-Mar-2023 via intramuscular route in right thigh for Immunisation. DILUENT LOT U7261AA , EXP 07-APR-2023 On 12-Apr-2023 the patient developed a non-serious event of administered the products acthib but the diluent was expired with no reported adverse event (expired product administered) 4 months 3 days following the administration of hib (prp/t) vaccine. Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event administered the products acthib but the diluent was expired with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2614147

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
CA
Alter
0,2
Geschlecht
F
Eingang
12.04.2023
Impfdatum
11.04.2023
Beginn
12.04.2023
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

N/A

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
erythromycin 5mg
Allergien
n/a
Vorherige Impfungen
-

VAERS 2614107

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
TX
Alter
1,0
Geschlecht
M
Eingang
12.04.2023
Impfdatum
10.04.2023
Beginn
10.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event Poor quality product administered

Symptomtext

caller confirmed that a dose of act-hib was administered in which the diluent has expired with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old male patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] in which the diluent has expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Prophylactic vaccination; and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination. On 10-Apr-2023, the patient received 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (DILUENT-Lot Number:U7261AA, Expiration Date :2023-04-07) (ACT-HIB-Lot Number:UJ679AA, Expiration Date :2023-05-28) (Frequency-ONCE) (Strength- Standard) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation). On 10-Apr-2023, the patient was administered HIB (PRP/T) Vaccine in which the diluent has expired with no reported adverse event (poor quality product administered) (Latency: same day). Action taken: not applicable. Outcome: Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
DTAP; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 2573359

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
CA
Alter
3,0
Geschlecht
F
Eingang
01.02.2023
Impfdatum
27.01.2023
Beginn
27.01.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Poor quality product administered Product preparation error

Symptomtext

On Friday Jan 27th, patient was administered ActHIB that was diluted with Sterile water instead of diluent that was provided with the vaccine. MA who diluted was unaware that this vaccine was paired with its own diluent. Mistake was caught the following Monday, Jan 30th. Dr was notified and manufacture was contacted. Manufacture stated that per CDC vaccine is invalid and needs to be re-administered. Dr will be contacting family shortly. As far as we know, no adverse reaction has been reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None/Unknown
Vorgeschichte
Eczema
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2563173

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
AZ
Alter
0,3
Geschlecht
F
Eingang
19.01.2023
Impfdatum
16.01.2023
Beginn
-
Tage bis Beginn
-
Dosis
2
Route/Site
- / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age

Symptomtext

First dose of Rotateq given past recommended age of 14 weeks, 6 days.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
N/A
Allergien
-
Vorherige Impfungen
-

VAERS 2545833

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ679AA

gering
Staat
LA
Alter
1,3
Geschlecht
M
Eingang
29.12.2022
Impfdatum
29.12.2022
Beginn
29.12.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event

Symptomtext

patient reports no symptoms

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
no
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-